Pathway for Novel Devices & New IVDs
Permissions to import or manufacture medical devices without an existing predicate, and new in-vitro diagnostic devices entering the Indian market. The first-of-its-kind regulatory pathway — used when no equivalent device is already classified. Involves an expert-committee review, additional clinical or analytical evidence, and a formal CDSCO classification decision before commercial licensing. Best engaged with early so the classification rationale shapes the downstream licence dossier.
4 CDSCO forms in this category
Application for Grant of Permission to Import/Manufacture for Sale or Distribution of Medical Devices Without Predicate Device
Application for permission to import or manufacture medical devices that do not have a predicate device.
Permission to Import/Manufacture for Sale or Distribution of Medical Devices Without Predicate Device
Permission granted to import or manufacture medical devices without a predicate device.
Application for Grant of Permission to Import/Manufacture New In Vitro Diagnostic Medical Devices
Application for permission to import or manufacture new IVD medical devices.
Permission to Import/Manufacture New In Vitro Diagnostic Medical Devices
Permission granted to import or manufacture new IVD medical devices.
When you need these licences
Use this list to confirm whether this category applies to your device, role, or use case.
No-predicate devices
Devices for which no substantially-equivalent predicate exists in the Indian CDSCO database.
New IVDs
IVDs detecting analytes or using methodologies not previously approved in India.
Strong clinical evidence
Pivotal clinical investigation or PER data demonstrating safety and effectiveness.
Documentation checklist
- Detailed device description and intended use
- Pivotal clinical investigation data (or PER for IVDs)
- Mechanism of action documentation
- Risk-benefit analysis
- Comparison to similar but non-equivalent devices
- Manufacturing and quality systems documentation
- Post-market surveillance commitment
Step by step
- 01
Pre-submission consultation
Optional pre-submission discussion with CDSCO clarifies expectations.
- 02
Pivotal evidence generation
Run pivotal clinical investigation or PER as required.
- 03
MD-26 / MD-28 filing
Application with full evidence package submitted.
- 04
Medical Device Advisory Committee review
Expert committee evaluates clinical evidence and intended use.
- 05
Permission grant (MD-27 / MD-29)
Permission to import/manufacture issued, often with specific conditions.
- 06
Subsequent commercial licensing
Permission feeds into commercial MD-9 / MD-15 application.
Common questions
When no substantially-equivalent device is already approved in the Indian CDSCO database. We check predicates carefully — sometimes a predicate exists that isn't obvious.
MD-26/27 is a pre-commercial permission focused on novel-device safety review. The commercial manufacturing licence (MD-9) follows after MD-27 is granted.
No — IVDs analogous to already-approved IVDs in the same category can often go directly to standard licensing. MD-28 applies to genuinely novel IVD methodologies or analytes.
6–12 months including clinical evidence generation, MDAC review, and permission grant. We help compress where possible.
Need help with novel device pathway?
We'll send a fixed-fee quote and indicative timeline within 48 hours.
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